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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE: 394 Adverse Event Reports & Safety Profile

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394
Total FAERS Reports
5 (1.3%)
Deaths Reported
138
Hospitalizations
394
As Primary/Secondary Suspect
29
Life-Threatening
26
Disabilities

Active Ingredient: DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE CALCIUM ·

First Report: 20030121 · Latest Report: 20250429

What Are the Most Common DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE Side Effects?

#1 Most Reported
Pulmonary embolism
84 reports (21.3%)
#2 Most Reported
Injury
80 reports (20.3%)
#3 Most Reported
Deep vein thrombosis
74 reports (18.8%)

All DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pulmonary embolism 84 21.3% 4 75
Injury 80 20.3% 2 66
Deep vein thrombosis 74 18.8% 1 56
Pain 53 13.5% 2 41
Emotional distress 52 13.2% 0 43
Drug dose omission 40 10.2% 0 0
Anxiety 35 8.9% 1 26
General physical health deterioration 31 7.9% 0 26
Off label use 27 6.9% 0 2
Metrorrhagia 23 5.8% 0 1
Dyspnoea 22 5.6% 1 19
Product use issue 22 5.6% 0 3
Thrombosis 22 5.6% 1 18
Anhedonia 20 5.1% 0 16
Nausea 19 4.8% 0 2
Pain in extremity 18 4.6% 0 12
Peripheral swelling 18 4.6% 0 12
Abdominal pain 17 4.3% 0 10
Cerebrovascular accident 16 4.1% 0 13
Abnormal withdrawal bleeding 15 3.8% 0 0

Who Reports DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE Side Effects? Age & Gender Data

Gender: 100.0% female, 0.0% male. Average age: 29.5 years. Most reports from: US. View detailed demographics →

Is DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 0 0
2005 1 0 1
2006 1 0 0
2007 1 0 0
2008 1 0 0
2009 2 0 2
2010 4 1 3
2011 36 0 27
2012 79 4 64
2013 13 0 9
2014 33 0 5
2015 34 0 5
2016 16 0 5
2017 13 0 1
2018 3 0 2
2019 7 0 2
2020 4 0 0
2021 8 0 3
2022 1 0 0
2023 1 0 0
2024 3 0 1
2025 2 0 1

View full timeline →

What Is DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE Used For?

IndicationReports
Contraception 118
Acne 27
Menstrual cycle management 14
Polycystic ovaries 14
Menorrhagia 13
Menstruation irregular 9
Premenstrual syndrome 8
Product used for unknown indication 8
Premenstrual dysphoric disorder 6

DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE vs Alternatives: Which Is Safer?

DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE vs DROTAVERINE DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE vs DROXIDOPA DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE vs DULAGLUTIDE DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE vs DULERA DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE vs DULOXETINE DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE vs DUPILUMAB DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE vs DURAGESIC DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE vs DUROGESIC DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE vs DUROTEP MT DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE vs DURVALUMAB

Official FDA Label for DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE

Official prescribing information from the FDA-approved drug label.